A Clinical Trial Comparing Glycaemic Control and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine (IGlar) as add-on Therapy to SGLT2i in Subjects With Type 2 Diabetes Mellitus (DUALTM IX)

August 10, 2020 updated by: Novo Nordisk A/S

A Clinical Trial Comparing Glycaemic Control and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine (IGlar) as add-on Therapy to SGLT2i in Subjects With Type 2 Diabetes Mellitus. DUALTM IX - Add-on to SGLT2i

This trial is conducted globally. The aim of this trial is comparing glycaemic control and safety of insulin degludec/liraglutide (IDegLira) versus insulin glargine (IGlar) as add-on therapy to SGLT2i (sodium-glucose cotransporter 2 inhibitors) in subjects with type 2 diabetes mellitus.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
420

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1425AGC
        • Novo Nordisk Investigational Site
      • Caba, Argentina, C1180AAX
        • Novo Nordisk Investigational Site
      • Caba, Argentina, C1120AAC
        • Novo Nordisk Investigational Site
      • Mendoza, Argentina, 5500
        • Novo Nordisk Investigational Site
  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2V 4W3
        • Novo Nordisk Investigational Site
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1G 1A7
        • Novo Nordisk Investigational Site
    • Ontario
      • Burlington, Ontario, Canada, L7M 4Y1
        • Novo Nordisk Investigational Site
      • London, Ontario, Canada, N6G 2M1
        • Novo Nordisk Investigational Site
      • Smiths Falls, Ontario, Canada, K7A 4W8
        • Novo Nordisk Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H4A 3T2
        • Novo Nordisk Investigational Site
  • Finland
      • Helsinki, Finland, 00100
        • Novo Nordisk Investigational Site
      • Lahti, Finland, 15110
        • Novo Nordisk Investigational Site
      • Oulu, Finland, FI-90220
        • Novo Nordisk Investigational Site
      • Rovaniemi, Finland, 96400
        • Novo Nordisk Investigational Site
      • Tampere, Finland, 33520
        • Novo Nordisk Investigational Site
      • Turku, Finland, 20520
        • Novo Nordisk Investigational Site
  • Hungary
      • Budapest, Hungary, 1042
        • Novo Nordisk Investigational Site
      • Debrecen, Hungary, 4043
        • Novo Nordisk Investigational Site
      • Komarom, Hungary, 2900
        • Novo Nordisk Investigational Site
      • Salgótarján, Hungary, 3100
        • Novo Nordisk Investigational Site
      • Szekszárd, Hungary, 7100
        • Novo Nordisk Investigational Site
      • Zalaegerszeg, Hungary, 8900
        • Novo Nordisk Investigational Site
  • India
      • New Delhi, India, 110001
        • Novo Nordisk Investigational Site
    • Andhra Pradesh
      • Hyderbad, Andhra Pradesh, India, 500 012
        • Novo Nordisk Investigational Site
    • Madhya Pradesh
      • Bhopal, Madhya Pradesh, India, 462037
        • Novo Nordisk Investigational Site
    • Maharashtra
      • Pune, Maharashtra, India, 411040
        • Novo Nordisk Investigational Site
    • Punjab
      • Ludhiana, Punjab, India, 141001
        • Novo Nordisk Investigational Site
    • Rajasthan
      • Jaipur, Rajasthan, India, 302004
        • Novo Nordisk Investigational Site
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600086
        • Novo Nordisk Investigational Site
      • Chennai, Tamil Nadu, India, 600029
        • Novo Nordisk Investigational Site
    • Uttar Pradesh
      • Varanasi, Uttar Pradesh, India, 221105
        • Novo Nordisk Investigational Site
    • West Bengal
      • Kolkata, West Bengal, India, 700054
        • Novo Nordisk Investigational Site
  • Russian Federation
      • Barnaul, Russian Federation, 656043
        • Novo Nordisk Investigational Site
      • Moscow, Russian Federation, 123423
        • Novo Nordisk Investigational Site
      • Novosibirsk, Russian Federation, 630047
        • Novo Nordisk Investigational Site
      • Saint-Petersburg, Russian Federation, 194358
        • Novo Nordisk Investigational Site
      • Saint-Petersburg, Russian Federation, 191119
        • Novo Nordisk Investigational Site
      • Saint-Petesburg, Russian Federation, 195257
        • Novo Nordisk Investigational Site
      • St. Petersburg, Russian Federation, 194354
        • Novo Nordisk Investigational Site
  • Slovakia
      • Kosice, Slovakia, 040 01
        • Novo Nordisk Investigational Site
      • Lucenec, Slovakia, 984 01
        • Novo Nordisk Investigational Site
      • Nitra, Slovakia, 94901
        • Novo Nordisk Investigational Site
      • Presov, Slovakia, 080 01
        • Novo Nordisk Investigational Site
      • Trnava, Slovakia, 91701
        • Novo Nordisk Investigational Site
  • Slovenia
      • Celje, Slovenia, SI-3000
        • Novo Nordisk Investigational Site
      • Koper, Slovenia, SI-6000
        • Novo Nordisk Investigational Site
      • Kranj, Slovenia, 4000
        • Novo Nordisk Investigational Site
      • Murska Sobota, Slovenia, SI-9000
        • Novo Nordisk Investigational Site
      • Trbovlje, Slovenia, 1420
        • Novo Nordisk Investigational Site
  • Spain
      • Almería, Spain, 04001
        • Novo Nordisk Investigational Site
      • Antequera, Spain, 29200
        • Novo Nordisk Investigational Site
      • Barcelona, Spain, 08035
        • Novo Nordisk Investigational Site
      • Boadilla del Monte, Spain, 28660
        • Novo Nordisk Investigational Site
      • Sevilla, Spain, 41003
        • Novo Nordisk Investigational Site
      • Sevilla, Spain, 41009
        • Novo Nordisk Investigational Site
      • Villamartin, Spain, 11650
        • Novo Nordisk Investigational Site
  • Switzerland
      • Baden, Switzerland, 5400
        • Novo Nordisk Investigational Site
      • Genève 14, Switzerland, 1211
        • Novo Nordisk Investigational Site
      • Luzern 16, Switzerland, 6000
        • Novo Nordisk Investigational Site
      • Olten, Switzerland, 4600
        • Novo Nordisk Investigational Site
      • Schaffhausen, Switzerland, 8208
        • Novo Nordisk Investigational Site
      • Winterthur, Switzerland, 8400
        • Novo Nordisk Investigational Site
      • Zollikerberg, Switzerland, 8125
        • Novo Nordisk Investigational Site
      • Zürich, Switzerland, 8091
        • Novo Nordisk Investigational Site
  • United States
    • Arizona
      • Glendale, Arizona, United States, 85308
        • Novo Nordisk Investigational Site
    • California
      • La Jolla, California, United States, 92037
        • Novo Nordisk Investigational Site
      • Mission Viejo, California, United States, 92691
        • Novo Nordisk Investigational Site
      • Northridge, California, United States, 91325
        • Novo Nordisk Investigational Site
      • Palm Springs, California, United States, 92262
        • Novo Nordisk Investigational Site
      • San Ramon, California, United States, 94583
        • Novo Nordisk Investigational Site
    • Florida
      • Boynton Beach, Florida, United States, 33472
        • Novo Nordisk Investigational Site
      • Chiefland, Florida, United States, 32626
        • Novo Nordisk Investigational Site
    • Illinois
      • Skokie, Illinois, United States, 60077
        • Novo Nordisk Investigational Site
    • Indiana
      • Avon, Indiana, United States, 46123
        • Novo Nordisk Investigational Site
    • Maryland
      • Rockville, Maryland, United States, 20852
        • Novo Nordisk Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89118
        • Novo Nordisk Investigational Site
    • New Jersey
      • Teaneck, New Jersey, United States, 07666
        • Novo Nordisk Investigational Site
    • New York
      • Albany, New York, United States, 12206
        • Novo Nordisk Investigational Site
      • West Seneca, New York, United States, 14224
        • Novo Nordisk Investigational Site
    • North Carolina
      • Whiteville, North Carolina, United States, 28472
        • Novo Nordisk Investigational Site
    • Ohio
      • Mason, Ohio, United States, 45040-6815
        • Novo Nordisk Investigational Site
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • Novo Nordisk Investigational Site
    • Tennessee
      • Bristol, Tennessee, United States, 37620-7352
        • Novo Nordisk Investigational Site
    • Texas
      • Austin, Texas, United States, 78731
        • Novo Nordisk Investigational Site
      • Houston, Texas, United States, 77081
        • Novo Nordisk Investigational Site
      • Longview, Texas, United States, 75605
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78228-3419
        • Novo Nordisk Investigational Site
    • Wisconsin
      • Kenosha, Wisconsin, United States, 53144
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: - Male or female, age at least 18 years at the time of signing informed consent - Subjects diagnosed (clinically) with type 2 diabetes mellitus - HbA1c 7.0-11.0% [53-97 mmol/mol] (both inclusive) by central laboratory analysis - Body mass index (BMI) equal to or above 20 kg/m^2 and below 40 kg/m^2 - Insulin naïve subjects; however short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as well as prior insulin treatment for gestational diabetes - A stable daily dose for at least 90 days prior to the day of screening of any SGLT2i in monotherapy or in combination with metformin ± DPP4i ± pioglitazone. Use of pioglitazone is not allowed in subjects treated with dapagliflozin Exclusion Criteria: - Receipt of any investigational medicinal product within 90 days prior to screening - Use of any OADs (other than SGLT2i in monotherapy or in combination with metformin or DPP4i or pioglitazone as described in the inclusion criteria) within 90 days prior to the day of screening - Use of glucagon-like peptide-1 (GLP-1) receptor agonist (e.g., exenatide or liraglutide) within 90 days prior to the day of screening - Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent severe metabolic dysregulation (e.g., diabetes ketoacidosis) in the previous 90 days prior to the day of the screening - Subjects presently classified as being in NYHA (New York Heart Association) Class III or IV1 - Renal impairment estimated Glomerular Filtration Rate 60 mL/min/1.73 m2 as per CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) - Impaired liver function, defined as ALT (alanine aminotransferase) equal to or above 2.5 times upper normal limit at screening - Known or suspected hypersensitivity to trial product(s) or related products

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: IDegLira
Drug: insulin degludec/liraglutide
IDegLira will be given subcutaneously ( s.c., under the skin) once daily.
Active Comparator: IGlar
Drug: insulin glargine
IGlar will be given subcutaneously ( s.c., under the skin) once daily.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in HbA1c (Glycosylated Haemoglobin)
Time Frame: Week 0, Week 26
The mean change from baseline (week 0) in HbA1c values evaluated after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.
Week 0, Week 26

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Body Weight
Time Frame: Week 0, Week 26
The mean change from baseline (week 0) in body weight evaluated after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.
Week 0, Week 26
Number of Treatment-emergent Severe or BG (Blood Glucose) Confirmed Symptomatic Hypoglycaemic Episodes
Time Frame: Week 0-26
Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe (subjects who were not able to self-treat) and/or BG confirmed by a plasma glucose values <3.1 mmol/L (56 mg/dL) with accompanied symptoms consistent with hypoglycaemia.
Week 0-26
Insulin Dose, Total Daily Dose (U)
Time Frame: After 26 weeks
Actual daily total insulin dose (Units) was evaluated after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.
After 26 weeks
Change in Fasting Plasma Glucose (FPG)
Time Frame: Week 0, Week 26
Change from baseline (week 0) in FPG was evaluated after 26 weeks of randomised treatment.
Week 0, Week 26
Number of Treatment-emergent Adverse Events
Time Frame: Week 0-26
Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 26. TEAE was defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment.
Week 0-26
Responder (Yes/No) for HbA1c Below 7.0%
Time Frame: After 26 weeks
The proportion of subjects achieving pre-defined HbA1c targets <7.0% after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.
After 26 weeks
Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Weight Gain
Time Frame: After 26 weeks
The proportion of subjects achieving pre-defined HbA1c targets <7.0% without weight gain after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.
After 26 weeks
Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment
Time Frame: After 26 weeks
The proportion of subjects achieving pre-defined HbA1c targets <7.0% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.
After 26 weeks
Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment and Without Weight Gain
Time Frame: After 26 weeks
The proportion of subjects achieving pre-defined HbA1c targets <7.0% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment and without weight gain. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.
After 26 weeks
Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5%
Time Frame: After 26 weeks
The proportion of subjects achieving pre-defined HbA1c targets ≤ 6.5% after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.
After 26 weeks
Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Weight Gain
Time Frame: After 26 weeks
The proportion of subjects achieving pre-defined HbA1c targets ≤ 6.5% without weight gain after 26 weeks of randomised treatment. The results are based on retrieved data at week 26 for subjects who prematurely discontinued the trial product.
After 26 weeks
Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment
Time Frame: After 26 weeks
The proportion of subjects achieving pre-defined HbA1c targets ≤ 6.5%without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.
After 26 weeks
Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment and Without Weight Gain
Time Frame: After 26 weeks
The proportion of subjects achieving pre-defined HbA1c targets ≤ 6.5%without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment and without weight gain. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.
After 26 weeks
Change From Baseline After 26 Weeks in Waist Circumference
Time Frame: After 26 weeks
Mean change from baseline in waist circumference after 26 weeks of randomised treatment.
After 26 weeks
Change From Baseline in Fasting Lipid Profile: Cholesterol
Time Frame: After 26 weeks
The values of total cholesterol from fasting lipid profile after 26 weeks of randomised treatment.
After 26 weeks
Change From Baseline in Fasting Lipid Profile: Low-density Lipoprotein Cholesterol (LDL Cholesterol)
Time Frame: After 26 weeks
The values of LDL cholesterol from fasting lipid profile after 26 weeks of randomised treatment.
After 26 weeks
Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein Cholesterol (HDL Cholesterol)
Time Frame: After 26 weeks
The values of HDL cholesterol from fasting lipid profile after 26 weeks of randomised treatment.
After 26 weeks
Change From Baseline in Fasting Lipid Profile: Very-low-density Lipoprotein Cholesterol (VLDL Cholesterol)
Time Frame: After 26 weeks
The values of VLDL cholesterol from fasting lipid profile after 26 weeks of randomised treatment.
After 26 weeks
Change From Baseline in Fasting Lipid Profile: Triglycerides
Time Frame: After 26 weeks
The values of triglycerides from fasting lipid profile after 26 weeks of randomised treatment.
After 26 weeks
Change From Baseline in Fasting Lipid Profile: Free Fatty Acids
Time Frame: After 26 weeks
The values of free fatty acids from fasting lipid profile after 26 weeks of randomised treatment.
After 26 weeks
Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile
Time Frame: After 26 weeks
Change in 9-point SMPG profile was evaluated after 26 weeks of randomised treatment. SMPG measurements at baseline and week 26 are presented here at the following mentioned time points:1) Before breakfast, 2) 90 mins after the start of Breakfast, 3) Before lunch, 4) 90 mins after the start of lunch, 5) Before dinner, 6) 90 mins after the start of dinner, 7) At bedtime, 8) At 4 AM, 9) Before breakfast the following day.
After 26 weeks
Change From Baseline in Self-measured Plasma Glucose (SMPG) 9-point Profile: Mean of the 9-point Profile
Time Frame: After 26 weeks
Change in mean of the 9-point profile SMPG was evaluated after 26 weeks of randomised treatment. 9-point profile SMPG was measured at the following mentioned time points:1) Before breakfast, 2) 90 mins after the start of Breakfast, 3) Before lunch, 4) 90 mins after the start of lunch, 5) Before dinner, 6) 90 mins after the start of dinner, 7) At bedtime, 8) At 4 AM, 9) Before breakfast the following day.
After 26 weeks
Change From Baseline in SMPG 9-point Profile: Prandial Plasma Glucose Increments (From Before Meal to 90 Min After Breakfast, Lunch and Dinner). The Mean Increment Over All Meals Will be Derived as the Mean of All Available Meal Increments
Time Frame: After 26 weeks
Mean prandial plasma glucose increments for each meal (from before meal to 90 min after breakfast, lunch and dinner) was evaluated after 26 weeks of randomised treatment. The mean increment over all meals was derived as the mean of all available meal increments are presented here.
After 26 weeks
Change From Baseline in Systolic Blood Pressure
Time Frame: After 26 weeks
Change from baseline (week 0) in systolic blood pressure (BP) was evaluated after 26 weeks of randomised treatment.
After 26 weeks
Change From Baseline in Diastolic Blood Pressure
Time Frame: After 26 weeks
Change from baseline (week 0) in diastolic blood pressure was evaluated after 26 weeks of randomised treatment.
After 26 weeks
Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks
Time Frame: Week 0-26
Number of treatment-emergent nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes (00:01-05:59 - inclusive) during 26 weeks of randomised treatment.
Week 0-26
Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition During 26 Weeks
Time Frame: Week 0-26
American Diabetes Association (ADA) classification of hypoglycaemic episodes: 1)Severe: Requiring assistance of another person to actively administer carbohydrate/glucagon/take other corrective actions. PG levels may not be available during an event, but neurological recovery following return of PG to normal is considered sufficient evidence that event was induced by a low PG level. 2) Documented symptomatic: PG ≤3.9 mmol/L with symptoms. 3) Asymptomatic: PG ≤3.9 mmol/L without symptoms. 4) Probable symptomatic: No measurement with symptoms. 5) Pseudo: PG >3.9 mmol/L with symptoms. 6) Unclassifiable.
Week 0-26
Change From Baseline in Clinical Evaluation After 26 Weeks: Electrocardiogram (ECG)
Time Frame: After 26 weeks
Reported results are ECG findings at screening and week 26 of randomised treatment. Since the values measured at the baseline (week 0) were not collected, the screening data (week -2, which is <= 2 weeks before baseline) is presented here. The findings are categorised as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). 4) Missing.
After 26 weeks
Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography
Time Frame: After 26 weeks
Reported results are fundus photography/fundoscopy (for both left and right eye) findings at screening and week 26 of randomised treatment. Since the values measured at the baseline (week 0) were not collected, the screening data (week -2, which is <= 2 weeks before baseline) is presented here. The findings are categorised as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). 4) Missing.
After 26 weeks
Change From Baseline in Clinical Evaluation After 26 Weeks: Pulse Rate
Time Frame: After 26 weeks
Change from baseline (week 0) in pulse rate was evaluated after 26 weeks of randomised treatment.
After 26 weeks
Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Medical Outcomes Study 36-item Short Form (SF-36v2)
Time Frame: After 26 weeks
The Short Form (SF)-36v2™ patient reported outcomes (PRO) questionnaire was used to assess the subject's overall health related quality of life (HRQoL). PRO questionnaire (SF-36v2™) measured the HRQoL which contains 36 items covering 8 domains of physical and mental health status. The raw scale scores from the SF-36 were transformed to a 0-100 scale scores (where higher scores indicated a better health status) which is further converted to norm-based scores using a T-score transformation in order to obtain a direct interpretation in relation to the distribution of the scores in the 2009 reference population . The total/overall (SF-36v2™) scores for physical and mental health from baseline to week 26 are presented here.
After 26 weeks
Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Treatment Related Impact Measure for Diabetes (TRIM-D)
Time Frame: After 26 weeks
The patient reported outcomes are calculated based on TRIM-D questionnaire. The TRIM-D questionnaire consists of 5 sub-domains (treatment burden, daily life, diabetes management, compliance and psychological health), where each question is scored to a 1-5-point scale with a higher score indicating a better health state (less negative impact). Mean TRIM-D domain scores and the total scores are later transformed to a 0-100 scale for analysis. Summary scores from baseline and week 26 for total/overall scores are presented here.
After 26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 23, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 26, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 23, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 13, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 16, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

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Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NN9068-4229
  • 2015-001596-48 (EudraCT Number)
  • U1111-1168-9343 (Other Identifier: WHO)
  • REec-2016-2248 (Other Identifier: REec)

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